Clinical- and Cost-effectiveness, Safety and Acceptability of Sequential Vitrectomy and Cataract Surgery vs Combined Phacovitrectomy for Rhegmatogenous Retinal Detachment: Randomised Equivalence Trial

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Background and study aims The retina is the layer at the back of the eye that allows us to see. Sometimes, it can detach from the wall of the eye, causing a condition called rhegmatogenous retinal detachment (RRD), which leads to vision loss and requires surgery. The most common surgery for RRD is vitrectomy, but this can lead to complications like cataracts, which worsen over time and need to be removed with another surgery. Cataract surgery involves replacing the cloudy lens with a clear artificial one. Currently, it's unclear whether it's better to perform both surgeries at the same time or separately. The COMBAT study aims to find out which approach is best by comparing the outcomes of patients who have vitrectomy alone versus those who have both surgeries (vitrectomy and cataract surgery by phacoemulsification and intraocular lens \[IOL\] implantation) together. Who can participate? Adults aged 50 and older who have RRD but are not highly myopic (less than -6 diopters or an axial length of 26.5 mm or less) and have not had previous vitreoretinal surgery. Participants must be scheduled for a pars plana vitrectomy to repair their RRD. What does the study involve? Participants will be randomly assigned to one of two groups: one group will have vitrectomy first and, if needed, cataract surgery later; the other group will have both surgeries at the same time. The study will compare their vision, the number of successful retina reattachments, health related and visual related quality of life, patient satisfaction, complications, additional surgeries and procedures, and costs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Adults ≥50 years of age

• Non-highly myopic (\< -6 diopters; ≤26.5 mm axial length) phakic RRD

• Naive to previous vitreoretinal surgery

• Pars plana vitrectomy is planned to repair their RRD

Locations
Other Locations
United Kingdom
Buckinghamshire Healthcare NHS Trust
RECRUITING
Aylesbury
Belfast Health and Social Care Trust
NOT_YET_RECRUITING
Belfast
Sandwell and West Birmingham Hospitals NHS Trust
NOT_YET_RECRUITING
Birmingham
Bradford Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Bradford
University Hospitals Bristol NHS Foundation Trust
NOT_YET_RECRUITING
Bristol
County Durham and Darlington NHS Foundation Trust
NOT_YET_RECRUITING
Darlington
NHS Greater Glasgow & Clyde
NOT_YET_RECRUITING
Glasgow
Hull University Teaching Hospitals NHS Trust
NOT_YET_RECRUITING
Hull
The Leeds Teaching Hospitals NHS Trust
NOT_YET_RECRUITING
Leeds
University Hospitals Leicester NHS Trust
NOT_YET_RECRUITING
Leicester
Liverpool University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Liverpool
Barts Health NHS Trust
NOT_YET_RECRUITING
London
Guys & St Thomas NHS Foundation Trust
NOT_YET_RECRUITING
London
King's College Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Moorfields Eye Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Manchester University NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
South Tees Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Middlesbrough
Newcastle Upon Tyne Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Newcastle Upon Tyne
Oxford University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Oxford
University Hospitals Plymouth NHS Trust
NOT_YET_RECRUITING
Plymouth
Royal Berkshire NHS Foundation Trust
NOT_YET_RECRUITING
Reading
Sheffield Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Sheffield
University Hospital Southampton NHS Foundation Trust
NOT_YET_RECRUITING
Southampton
South Tyneside and Sunderland NHS Trust
NOT_YET_RECRUITING
Sunderland
Mid & South Essex NHS Foundation Trust
NOT_YET_RECRUITING
Westcliff-on-sea
The Royal Wolverhampton NHS Trust
NOT_YET_RECRUITING
Wolverhampton
York and Scarborough Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
York
Contact Information
Primary
Colette Jackson
colette.jackson@nictu.hscni.net
+44 28 96151447
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2028-05-08
Participants
Target number of participants: 276
Treatments
Active_comparator: Phacovitrectomy
Active_comparator: Vitrectomy
Sponsors
Leads: Queen's University, Belfast
Collaborators: Northern Ireland Clinical Trials Unit

This content was sourced from clinicaltrials.gov